Chest PainACUTE CTNCT00855231
Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain
An observational study of Chest Pain and Acute Coronary Syndrome, run by University of Washington at 1 site in United States.
Trial summary
The ACUTE CT trial is designed to test whether the assessment of chest structures by high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy for patient with acute chest pain or other potential cardiac symptoms as compared to a standard of care evaluation. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome, Pulmonary Embolism
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Alll patients presenting to the University of Washington Medical Center Emergency Department with possible acute coronary syndrome
Who may be able to join
- Low to intermediate risk of angina with a TIMI ACS Risk Score ≤ 4
- chest pain or other symptoms suggestive of ACS within 24 hours
- male ≥30 years or female ≥45 years old
- at least one cardiac risk factor
- no obvious cause for symptoms.
Who cannot join
- known CAD
- ST segment elevation, new left bundle branch block or dynamic ECG changes
- creatinine ≥1.8 g/dL
- pregnant or lactating female
- hemodynamic or respiratory instability
- ongoing bronchospasm
- known iodinated contrast allergy
- atrial fibrillation or irregular heart rate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain - Assessment of Chest Pain Utilizing a Triple Rule Out Evaluation With Computed Tomography (ACUTE CT) Trial
The ACUTE CT trial is designed to test whether the assessment of chest structures by high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy for patient with acute chest pain or other potential cardiac symptoms as compared to a standard of care evaluation.
Read the detailed description
Adults at low to intermediate risk of acute coronary syndrome who present to the Emergency Department with symptoms suggestive of cardiac ischemia will undergo a blinded cardiac CT followed by a standard of care (SOC) strategy. Significant coronary artery disease on CT (coronary stenosis >50%) will be compared to an adjudicated diagnosis derived from clinical data and other diagnostic tests based on the SOC strategy. Costs for the SOC evaluation will be collected and compared to a CT-based evaluation. Patients will be followed for 3 years after enrollment to evaluate prognosis.
- Keywords
- Acute coronary syndrome, Coronary artery disease, cardiac imaging, computed tomography
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Pulmonary Embolism, Aortic Dissection, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CT compared to standard of care evaluation
Measured: 3 months
Secondary outcomes (1)
Cost savings of CT-based evaluation compared to the standard of care evaluation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startJul 2006
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Kelley Branch, University of Washington
- Investigators
- Kelley R Branch, MD, Principal investigator, University of WashingtonWilliam P Shuman, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855231
- Sponsor's protocol ID
- 27903-D
- Other IDs
- 05-6337-D 03
- Acronym
- ACUTE CT
- Status last verified
- Nov 2017
- First submitted
- 3 Mar 2009
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Branch KR, Busey J, Mitsumori LM, Strote J, Caldwell JH, Busch JH, Shuman WP. Diagnostic performance of resting CT myocardial perfusion in patients with possible acute coronary syndrome. AJR Am J Roentgenol. 2013 May;200(5):W450-7. doi: 10.2214/AJR.12.8934.
PubMed 23617513Branch KR, Strote J, Shuman WP, Mitsumori LM, Busey JM, Rue T, Caldwell JH. Diagnostic accuracy and clinical outcomes of ECG-gated, whole chest CT in the emergency department. PLoS One. 2013 Apr 16;8(4):e61121. doi: 10.1371/journal.pone.0061121. Print 2013.
PubMed 23613797Branch KR, Bresnahan BW, Veenstra DL, Shuman WP, Weintraub WS, Busey JM, Elliott DJ, Mitsumori LM, Strote J, Jobe K, Dubinsky T, Caldwell JH. Economic outcome of cardiac CT-based evaluation and standard of care for suspected acute coronary syndrome in the emergency department: a decision analytic model. Acad Radiol. 2012 Mar;19(3):265-73. doi: 10.1016/j.acra.2011.10.029. Epub 2011 Dec 30.
PubMed 22209422May JM, Shuman WP, Strote JN, Branch KR, Mitsumori LM, Lockhart DW, Caldwell JH. Low-risk patients with chest pain in the emergency department: negative 64-MDCT coronary angiography may reduce length of stay and hospital charges. AJR Am J Roentgenol. 2009 Jul;193(1):150-4. doi: 10.2214/AJR.08.2021.
PubMed 19542407Shuman WP, Branch KR, May JM, Mitsumori LM, Strote JN, Warren BH, Dubinsky TJ, Lockhart DW, Caldwell JH. Whole-chest 64-MDCT of emergency department patients with nonspecific chest pain: Radiation dose and coronary artery image quality with prospective ECG triggering versus retrospective ECG gating. AJR Am J Roentgenol. 2009 Jun;192(6):1662-7. doi: 10.2214/AJR.08.1872.
PubMed 19457832Mitsumori LM, Wang E, May JM, Lockhart DW, Branch KR, Dubinsky TJ, Shuman WP. Triphasic contrast bolus for whole-chest ECG-gated 64-MDCT of patients with nonspecific chest pain: evaluation of arterial enhancement and streak artifact. AJR Am J Roentgenol. 2010 Mar;194(3):W263-71. doi: 10.2214/AJR.09.2788.
PubMed 20173125Shuman WP, May JM, Branch KR, Mitsumori LM, Strote JN, Green DE, Caldwell JH. Negative ECG-gated cardiac CT in patients with low-to-moderate risk chest pain in the emergency department: 1-year follow-up. AJR Am J Roentgenol. 2010 Oct;195(4):923-7. doi: 10.2214/AJR.09.3972.
PubMed 20858819
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Multislice CT Angiography for Acute Chest Pain - Assessment of Chest Pain Utilizing a Triple Rule Out Evaluation With Computed Tomography (ACUTE CT) Trial
- ClinicalTrials.gov ID
- NCT00855231
- Acronym / sponsor ID
- ACUTE CT / 27903-D
- Keywords
- Acute coronary syndrome, Coronary artery disease, cardiac imaging, computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Jul 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ACUTE CT trial is designed to test whether the assessment of chest structures by high-resolution multislice computed tomography (CT) provides equivalent diagnostic accuracy for patient with acute chest pain or other potential cardiac symptoms as compared to a standard of care evaluation.
Detailed description
Adults at low to intermediate risk of acute coronary syndrome who present to the Emergency Department with symptoms suggestive of cardiac ischemia will undergo a blinded cardiac CT followed by a standard of care (SOC) strategy. Significant coronary artery disease on CT (coronary stenosis >50%) will be compared to an adjudicated diagnosis derived from clinical data and other diagnostic tests based on the SOC strategy. Costs for the SOC evaluation will be collected and compared to a CT-based evaluation. Patients will be followed for 3 years after enrollment to evaluate prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Alll patients presenting to the University of Washington Medical Center Emergency Department with possible acute coronary syndrome
Key inclusion criteria (5 listed)
- Low to intermediate risk of angina with a TIMI ACS Risk Score ≤ 4
- chest pain or other symptoms suggestive of ACS within 24 hours
- male ≥30 years or female ≥45 years old
- at least one cardiac risk factor
- no obvious cause for symptoms.
Key exclusion criteria (8 listed)
- known CAD
- ST segment elevation, new left bundle branch block or dynamic ECG changes
- creatinine ≥1.8 g/dL
- pregnant or lactating female
- hemodynamic or respiratory instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of CT compared to standard of care evaluation
Time frame: 3 months
1 secondary outcome
Cost savings of CT-based evaluation compared to the standard of care evaluation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Background: PubMed 23617513Branch KR, Busey J, Mitsumori LM, Strote J, Caldwell JH, Busch JH, Shuman WP. Diagnostic performance of resting CT myocardial perfusion in patients with possible acute coronary syndrome. AJR Am J Roentgenol. 2013 May;200(5):W450-7. doi: 10.2214/AJR.12.8934.
- Background: PubMed 23613797Branch KR, Strote J, Shuman WP, Mitsumori LM, Busey JM, Rue T, Caldwell JH. Diagnostic accuracy and clinical outcomes of ECG-gated, whole chest CT in the emergency department. PLoS One. 2013 Apr 16;8(4):e61121. doi: 10.1371/journal.pone.0061121. Print 2013.
- Background: PubMed 22209422Branch KR, Bresnahan BW, Veenstra DL, Shuman WP, Weintraub WS, Busey JM, Elliott DJ, Mitsumori LM, Strote J, Jobe K, Dubinsky T, Caldwell JH. Economic outcome of cardiac CT-based evaluation and standard of care for suspected acute coronary syndrome in the emergency department: a decision analytic model. Acad Radiol. 2012 Mar;19(3):265-73. doi: 10.1016/j.acra.2011.10.029. Epub 2011 Dec 30.
- Results publication: PubMed 19542407May JM, Shuman WP, Strote JN, Branch KR, Mitsumori LM, Lockhart DW, Caldwell JH. Low-risk patients with chest pain in the emergency department: negative 64-MDCT coronary angiography may reduce length of stay and hospital charges. AJR Am J Roentgenol. 2009 Jul;193(1):150-4. doi: 10.2214/AJR.08.2021.
- Results publication: PubMed 19457832Shuman WP, Branch KR, May JM, Mitsumori LM, Strote JN, Warren BH, Dubinsky TJ, Lockhart DW, Caldwell JH. Whole-chest 64-MDCT of emergency department patients with nonspecific chest pain: Radiation dose and coronary artery image quality with prospective ECG triggering versus retrospective ECG gating. AJR Am J Roentgenol. 2009 Jun;192(6):1662-7. doi: 10.2214/AJR.08.1872.
- Results publication: PubMed 20173125Mitsumori LM, Wang E, May JM, Lockhart DW, Branch KR, Dubinsky TJ, Shuman WP. Triphasic contrast bolus for whole-chest ECG-gated 64-MDCT of patients with nonspecific chest pain: evaluation of arterial enhancement and streak artifact. AJR Am J Roentgenol. 2010 Mar;194(3):W263-71. doi: 10.2214/AJR.09.2788.
- Results publication: PubMed 20858819Shuman WP, May JM, Branch KR, Mitsumori LM, Strote JN, Green DE, Caldwell JH. Negative ECG-gated cardiac CT in patients with low-to-moderate risk chest pain in the emergency department: 1-year follow-up. AJR Am J Roentgenol. 2010 Oct;195(4):923-7. doi: 10.2214/AJR.09.3972.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelley R Branch, MD principal investigator
University of Washington
William P Shuman, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain and Acute Coronary Syndrome, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CT compared to standard of care evaluation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855231, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.